BONE
BIOLOGICS CORPORATION
September
24, 2015
Bone Biologics
Corporation
000 Xxxxxxxx
Xxx.
Boston,
MA 02116
Attention:
Founders
Dear Drs.
Xxx, Xxxx and Xx:
| 1. | This
letter agreement has been written to confirm our understanding regarding the past work
product and past data related to Xxxx-1. By executing this Agreement Xxx Xx, Xxxx Xxx
and Xxxx Xxxx Xxxx (the “Founders”) hereby agree to deliver all past work
product and past data related to Xxxx-1 (the “Data”) which Bone Biologics
Corporation (“Bone Bio”) deems to have value to Bone Bio as it progresses
to and commences the manufacturing of Xxxx-1 (the “Data”), as set forth on
Schedule I attached hereto. The Founders are not asked to perform additional research
or produce new data. The Founders agree that Bone Biologics shall have the right to use
the Data in its sole discretion, within the applicable licensing rights granted by the
University of California, beginning as of the date hereof and that such right shall not
be subject to termination in any way by the Founders. Absent any additional agreement
between Bone Bio and the Founders, it is understood that the Founders will have no further
obligation to Bone Bio to provide work product or any other services beyond what is contained
herein as defined in Schedule I. |
Bone
Bio agrees to issue 1,153,846 shares of restricted common stock to the Founders in the percentages set forth on Annex I attached
hereto (the “Shares”) on the earlier to occur of (i) the third anniversary of the date hereof and (ii) a “Liquidity
Event” which shall mean Bone Bio’s initial public offering or APO/OTCB/PIPE/PPM/PREFERRED CONVERT or sale in exchange
for reasonable efforts by Founders to provide the work product and data set forth in Schedule I attached hereto. For transactions
and liquidity events that involve customary lockup periods, the Shares shall vest on the expiration date of the lock-up period.
The Founders agree to accept the Shares in full satisfaction for the delivery of the Data.
The
Founders understand that the Shares are restricted and may not be sold, transferred or otherwise disposed of without registration
under the Securities Act of 1933, as amended (the “Securities Act”) or an exemption therefrom, and that in the absence
of an effective registration statement covering the Shares or an available exemption from registration under the Securities Act,
the Shares must be held indefinitely. Bone Bio will register these Shares on behalf of the Founders at the earliest opportunity
as permitted under the Securities Act of 1933 (the “Act”). The certificate or certificates representing the Shares
shall bear the following legends (as well as any legends required by applicable state and federal corporate and securities laws);
provided however, that once the Shares are registered for resale pursuant to the Act such legend will be removed upon the sale
of such Shares:
THE
SHARES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AND HAVE BEEN ACQUIRED FOR INVESTMENT
AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH SALE OR DISTRIBUTION MAY BE EFFECTED
WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE COMPANY THAT
SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933.
The
Founders represent and warrant to Bone Bio that each is an “accredited investor,” as such term is defined in Rule
501(a) of Regulation D of the Securities Act.
In
the event that Bone Bio pursues an equity financing of common stock, inclusive of, and not limited to, any exercise of warrant
options Bone Bio shall request that the placement agent include an aggregate of up to $2,250,000 worth of common stock owned by
the Founders (the “Founders Shares”) in such equity financing. If the placement agent advises Bone Bio that in their
opinion the Founders Shares requested to be included in such private placement exceeds the number of shares of common stock which
can be sold in such offering on behalf of the Company without adversely affecting the marketability of such offering for the Company,
the Company will include common stock in such financing in accordance with the following formula: for each $1,000,000, the Founders
shall be allowed to sell $250,000 of Founders common shares until the Founders Shares as defined herein are sold provided that
Bone Bio fully discloses in the use of proceeds the intent to sell such Founders Shares to the Placement Agent or the investor(s),
as applicable. Founders agree that the foregoing right shall not be applicable to any public offering of the Company’s securities,
which would be subject to customary restrictions and lock-up periods required by the Company’s underwriter in connection
with such public offering. Founders acknowledge that the Company makes no warranties to Founders that any Founder Shares will
be sold, and any such sale is subject to acceptance by Placement Agent or the investor(s), as applicable.
| 2. | The
Founders will deliver the Data to: |
Xxxxxxx
XxXxxx
Bone
Biologics Corporation
000
Xxxxxxxx Xxx
Boston,
MA 02116
All
Data provided may be used in Bone Bio’s discretion within the applicable licensing rights granted by the University of California.
The
parties shall comply with all applicable laws, rules and regulations, including the federal false claims statute (31 U.S.C. 3729)
and anti-kickback statute (42 U.S.C. 1320a-7 (b)) and the related safe harbor regulations. Accordingly, no part of any consideration
paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items
or services. If any portion of this Agreement is found by any court or agency with jurisdiction over the subject matter hereof
not to be in compliance, that portion of the Agreement shall be deemed retroactively amended and reformed as necessary to comply
and the parties shall cooperate in taking such actions as are necessary and desirable to ensure such compliance.
a.
This Agreement constitutes the sole, full and complete agreement by and between the parties with regard to the subject of this
Agreement, and no amendments, changes, additions, deletions, or modifications of this Agreement will be valid unless reduced to
writing, signed by the parties, and attached hereto.
b.
This Agreement will not be considered accepted, approved, or otherwise effective until the signature of each party is affixed
in the space provided below and written documentation of Bone Bio Board approval for this Agreement is also obtained. Please be
advised that a fully executed Agreement with Bone Bio approval must be received by Founders and Bone Bio within 7 business days
of the above date. If not received within that period, either party reserves the right to re-evaluate the terms of this Agreement.
c.
This Agreement may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument
and shall become effective when counterparts have been signed by each party and delivered to the other parties hereto, it being
understood that all parties need not sign the same counterpart. Execution may be made by delivery by facsimile or via electronic
format.
All
communications hereunder, except as may be otherwise specifically provided herein, shall be in writing and shall be mailed, hand
delivered, sent by a recognized overnight courier service such as Federal Express, or sent via facsimile/electronic mail and confirmed
by letter, to the party to whom it is addressed at the following addresses or such other address as such party may advise the
other in writing:
To
Bone Bio: as set forth on the signature page hereto.
To
the Founders: as set forth on the signature page hereto.
All
notices hereunder shall be effective upon receipt by the party to which it is addressed.
d.
Any rights or obligations contained herein that by their nature should survive termination of this Agreement shall survive, including,
but not limited to, acknowledgments and use of Data.
e.
This Agreement shall be governed by and construed in accordance with the laws of California without regard to choice of law principles.
The parties hereby consent to jurisdiction in the State of California and agree that the courts within California shall have exclusive
jurisdiction over any issue regarding this Agreement.
f.
The parties may modify or amend this Agreement only pursuant to written agreement signed by all parties.
g.
If any provisions of this Agreement or application to any party or circumstances shall be determined by any court of competent
jurisdiction to be invalid and unenforceable to any extent, the remainder of this Agreement, or the application of such provisions
or circumstances other than those as to which it is determined to be invalid or unenforceable shall not be affected thereby, and
each provision hereof shall be valid and shall be enforced to the fullest extent permitted by law.
h.
The failure of any party to insist upon a strict performance of or to seek remedy of any one of the terms or conditions of this
Agreement or to exercise any right, remedy or election set forth herein or permitted by law shall not constitute nor be construed
as a waiver or relinquishment for the future enforcement of such term, condition, right, remedy or election, but such items shall
continue and remain in force and effect. All rights or remedies of any party specified in this Agreement and all other rights
or remedies that either party may have at law, in equity or otherwise shall be distinct, separate and cumulative rights or remedies,
and no one of them, whether exercised by the party seeking enforcement or not, shall be deemed to be in exclusion of any other
right or remedy of such party. Any consent, waiver or approval by either party of any act or matter must be in writing and shall
apply only to the particular act or matter to which such consent or approval is given.
If
the foregoing terms meet with your approval, kindly confirm your acceptance by dating, signing and returning to us the copy of
this letter enclosed for that purpose.
| |
Very
truly yours, |
| |
|
| |
Bone Biologics
Corporation |
| |
By:
|
/s/
Xxxxxxx X. XxXxxx |
| |
Name: |
Xxxxxxx X. XxXxxx |
| |
Title: |
CEO |
| |
Date: |
October 8, 2015 |
| |
Address
for Notice: |
| |
000 Xxxxxxxx Xxx |
| |
Boston, MA 02116 |
AGREED
AND ACCEPTED:
| By:
|
/s/
Xx. Xxxx Xxx |
|
Date: 10/1/15 |
| Name:
|
Xx.
Xxxx Xxx |
|
|
|
| Title:
|
Founder |
|
|
|
| By:
|
/s/
Xx. Xxxx Xxxx Xxxx |
|
Date: 10/1/15 |
| Name:
|
Xx.
Xxxx Xxxx Xxxx |
|
|
|
| Title:
|
Founder |
|
|
|
| By:
|
/s/
Xx. Xxx Xx |
|
Date: 10/8/15 |
| Name:
|
Xx.
Xxx Xx |
|
|
|
| Title:
|
Founder |
|
|
|
Annex
1
| Founder | |
| Percentage | |
| | |
| | |
| Xxx Xx | |
| 33
1/3 | % |
| | |
| | |
| Chia Soo | |
| 33
1/3 | % |
| | |
| | |
| Xxxx Xxxx Xxxx | |
| 33
1/3 | % |
Schedule
1
| 1. | Full
access to Xxxxxx’s Data from Xxxxxx’s efforts to produce Xxxx-1 from 2009
to present for technology transfer package for CDMO. Bone Bio acknowledges the fact that
the Founders have no control over Xxxxxx’s records and lab notebooks, and can only
provide access. |
| a. | Analytical
data for each step of the process to gain an understanding of what worked and what has
not worked regarding the assays, bioreactor runs, purification runs, etc. |
| b. | Inoculum
scale up data such as age of the culture at the time of bioreactor inoculation |
| c. | Bioreactor
profile parameters |
| viii. |
| medium
supplements during culture |
| ix. |
| protein
concentration |
| x. |
| ratio
of pass to fail runs |
| d. | Final
cell density, viability and titer before clarification at harvest |
| i. |
| Run
time parameters such as length of time to clarify, temperature, any concentration steps
used |
| ii. |
| Type
of clarification material used |
| iii. |
| Titer
post clarification |
| iv. |
| Hold
time between harvest, clarification and initial capture step |
| f. | Data
on Xxxx-1 stability during viral inactivation steps as part of the purification process |
| g. | Capture
column parameters |
| i. |
| Protein
loading (concentration per mL loaded) |
| ii. |
| Total
protein loaded per run |
| iv. |
| Flow
rate (residence time) |
| vi. |
| Binding
capacity of resin |
| vii. |
| Yield
loss (pass through Xxxx-1 that did not bind to column) |
| ix. |
| Potency
(active molecule) post capture |
| x. |
| SDS-PAGE
and SDS analysis |
| xi. |
| Co-purifying
proteins |
| xii. |
| Other
analytics employed to provide data |
| i. |
| Data
for removal of HCP, DNA/RNA |
| i. |
| Final
purity of each lot |
| j. | Nano
filtration process |
| k. | Aseptic
sterilization process |
| l. | Formulation
of final bulk product |
| i. |
| How
was this determined |
| ii. |
| How
long and under what parameters can the product be held without compromising quality |
| m. | Hold
times and conditions at each step of the process |
| i. |
| Is
there data that could be used to develop the initial hold time parameter at each step |
| n. | Characterization
of Xxxx-1 at various production steps |
| i. |
| Any
attempts and data where non-denatured GEL bands were separated and analyzed for activity |
| ii. |
| Any
attempts and data to separate higher order species via SEC and analyzed for activity |
| iii. |
| Any
attempts and data to prevent aggregation of Xxxx-1 into higher species |
| iv. |
| Any
data on deamination or oxidation of Xxxx-1 |
| v. |
| Any
data on the effect of endogenous proteases |
| o. | What
lots produced acceptable product and what lots did not produce acceptable product |
| |
| | Any
discussions with Xxxxxx on possible solutions |
| a. | Any
initial data on the development of a lyo cycle |
| b. | Any
initial data on the development of a lyo formulation |
| c. | Stability
data on lyophilized Xxxx-1 |
| d. | Any
know effects of moisture or temperature on the lyophilized Xxxx-1 |
| e. | Capacity
of apatite coated TCP for Xxxx-1 |
| f. | Elution
profile of Xxxx-1 from apatite coated TCP |
| g. | Assay
to monitor active Xxxx-1 eluted from TCP |
| h. | Thoughts
on delivery device |
| 3. | Potency
assay SOP as run at UCLA. |
| a. | List
of all reagents and their sources |
| b. | Data
on how control was established |
| c. | Actual
protocol for potency assay |
| d. | Data
on the performance of each Xxxx-1 lot evaluated |
| e. | Have
there been times when the assay did not work on a sample, but upon re-running the sample
worked (MTBF) |
| f. | Have
there been times when the control also failed in the assay |
| g. | How
was this assay qualified |
| h. | Will
need their assistance during any equivalence testing between their current assay and
any newly developed potency assay |
| 4. | Performance
data on how the quality of regenerated bone post exposure to Xxxx-1 was measured and
determined |
| a. | Data
on host antibody production after the application of Xxxx-1 during early research in
rodent models |
| b. | Similar
data for the sheep and monkey experiments |
| 6. | Xxxx-1
Distribution data |
| a. | Data
on the distribution of Xxxx-1 after local application in rodent models |
| b. | Similar
data for the sheep and monkey experiments |
| a. | Methods
for establishing dosing for rodents, sheep, monkey |
| b. | Dosing
range estimate for humans and methodology for such |
| c. | Effects
noted or anticipated for overdosing |
| 8. | Biocompatibility
data for protein |
| 9. | Absorption,
distribution, metabolism and excretion (ADME) data in rodent, sheep and monkey studies |
| a. | Stability
data of Xxxx-1 once mixed with DBX (initial time post mixing that should not be exceeded
prior to application) |
| b. | Protocol
or current thinking on how to obtain uniform mixing of powdered Xxxx-1 with DBX |
| c. | Half
life of Xxxx-1 in DBX after implantation in rodent, sheep and monkey models |
| 11. | Bone
Biologics & UCLA Discovery Grant No bio07-10677. |
| a. | Beyond
a summary letter and can find no records in the files |
| b. | Need
deliverable of data produced during this project. |
| i. |
| Bioassays
to Confirm UCB Bioactivity |
| ii. |
| Synthetic
Carriers to enhance UCB bioactivity |
| iii. |
| UCB
is safer than BMP-2 |
| iv. |
| UCB
supports stem cell growth and differentiation |
| v. |
| UCB
can potentially work within osteoporotic environment |
| vi. |
| In-depth
MicroCT Analysis of UCB induced Bone Formation in Sheep and Primate Models |
| a. | Written
and approved protocol |
| c. | Data
from SF9 derived Xxxx-1 |
| d. | Data
from CHO derived Xxxx-1 |
| f. | Final
report from Colorado State University |
| g. | Summary
of what the founders believe are the key points of the data |
| a. | Written
and approved protocol |
| c. | Data
from SF9 derived Xxxx-1 |
| d. | Data
from CHO derived Xxxx-1 |
| f. | Final
report of China company who ran the studies |
| g. | Summary
of the key points of the data |
